Status:
COMPLETED
A Study of Strawberries and Disease Risk
Lead Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborating Sponsors:
California Strawberry Commission
Conditions:
Nutritional and Metabolic Diseases
Inflammation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to test whether compounds found in strawberries (polyphenolics which are typically found in berry products, tea, coffee, red wine, and chocolate) will help reduce insulin ...
Detailed Description
The main study is a single-center, randomized, cross-over, 4-arm, dose-response, single- blinded, 6-hour postprandial study to evaluate the ability of strawberry powder to block meal-induced oxidative...
Eligibility Criteria
Inclusion
- Eligible volunteers must meet ONE or MORE of the criteria (numbers 1-4) associated with insulin resistance along with all of the other criteria listed (numbers 5-9):
- Blood glucose concentration between140-199 mg/dL at 2hr from OGTT.
- Elevated fasting glucose (≥110 mg/dL and \<126 mg/dL)
- Elevated fasting insulin (\>75th percentile cutoff of 13.13 μU/mL)
- Insulin resistance defined by the homeostasis model assessment method of insulin resistance (HOMA-IR) (glucose \[in millimoles per liter\] × insulin \[in microunits per milliliter\]/22.5) values of at least 2.5.
- Waist circumference \>102 cm (men) and \> 88 cm (women) for screening visit invitation because many epidemiology studies have been shown that waist circumferences may be related to insulin resistance.
- Nonsmokers
- Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements
- 18 years of age and older
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
Exclusion
- Pregnant and/or lactating
- Allergy or intolerance to strawberries and dairy products.
- Current regular consumption of strawberries is \> 2 servings per day.
- Fasting blood glucose ≥ 126 mg/dL. Subjects identified with elevated fasting blood glucose levels will be advised to contact their primary care physician for appropriate follow-up care.
- Taking over the counter antioxidant supplements or other supplements that may interfere with the study procedures or endpoints.
- Subjects with unusual dietary habits (e.g. pica).
- Actively losing weight or trying to lose weight (unstable body weight fluctuations of \> 5 kg in a 60 day period).
- Excessive exercisers or trained athletes.
- Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, or other systemic diseases.
- Addicted to drugs and/or alcohol.
- Medically documented psychiatric or neurological disturbances.
- Smoker (past smoker may be allowed if cessation is \> 2 years)
Key Trial Info
Start Date :
September 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01199848
Start Date
September 15 2010
End Date
October 15 2015
Last Update
February 12 2021
Active Locations (1)
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1
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616